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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC ZINGER XT; OCCLUDER, CATHETER TIP
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MEDTRONIC, INC ZINGER XT; OCCLUDER, CATHETER TIP Back to Search Results
Model Number LVZRXT180S
Medical Device Problem Codes Material Fragmentation (1261); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/18/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during the procedure, the guidewire became stuck in the left ventricular (lv) lead and broke off.The guidewire is still in the coronary vein.An extraction was planned.No patient complications have been reported as a result of this event.
 
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Brand Name
ZINGER XT
Common Device Name
OCCLUDER, CATHETER TIP
Manufacturer (Section D)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
MDR Report Key10617221
Report Number1220452-2020-00081
Device Sequence Number11083114
Product Code DQT
UDI-Device Identifier00643169452282
UDI-Public00643169452282
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K983927
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date04/24/2022
Device Model NumberLVZRXT180S
Device Catalogue NumberLVZRXT180S
Device Lot NumberG19A03854
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/18/2020
Initial Report FDA Received Date10/01/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
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